More than 200,000 bottles of the diabetes drug Glumetza have been recalled due to the same chemical contamination from wood pallets that led to a Tylenol recall late last year.
The Glumetza recall was announced this week by the manufacturer, Depomed, in a June 17 Security Exchange Commission (SEC) filing for investors. The recalled drugs are believed to be contaminated with a chemical called 2,4,6, tribromoanisole (TBA), which may have leached into bottles from wood pallets treated with pesticide. The contamination was discovered after the company received a complaint regarding the smell and taste of the drug.
TBA can cause temporary gastrointestinal illness when present in certain amounts. The same type of contamination forced Johnson & Johnson to announce a Tylenol recall in December. That recall has been expanded twice to affect a number of Johnson & Johnson products, including a Tylenol recall expansion announced earlier this month.
In total, about 56 million bottles of over-the-counter drugs from the Johnson & Johnson’s McNeil Consumer Healthcare subsidiary have been recalled due to the contamination. The contamination was first detected by consumers who reported a musty smell emanating from bottles of medication.
The Glumetza recall affects 52 lots of 500mg tablets. Each lot contains approximately 4,000 bottles. The company has not yet released a list of lot numbers affected by the recall. The diabetes drug recall does not affect bottles of 1,000mg Glumetza.
Depomed said in its SEC filing that it believes the contamination came from wood pallets used to ship Glumetza bottles from its contract manufacturer in Puerto Rico. The company says that it has ceased shipping Glumetza 500mg on the pallets and is requiring its bottle supplier to do the same.
The company said it has alerted FDA and is working with the agency on an investigation and expects shipments of Glumetza 500mg to continue in four to eight weeks. The recall is expected to cost the company about $2 million.
The FDA has not yet issued a press release or recall announcement, and the Depomed filing did not have recall instructions for customers.